EUCTR2020-002192-35-FI进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of BAY 2327949 in patients with chronic kidney disease (eGFR range from 25 to 60 mL/min/1.73 m²) due to type 2 diabetes or hypertension and at least one cardiovascular comorbidity - ASSESS-CKD
Bayer - AG0 个研究点目标入组 120 人开始时间: 2020年8月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Participant must be 45 years or older at the time of signing the informed consent.
- •2. A clinical diagnosis of CKD meeting all of the following criteria:
- •?eGFR = 25 mL/min/1.73 m² but = 60 mL/min/1.73 m² (estimated using the CKD-EPI equation) as assessed during Visit 1
- •?albuminuria (as measured by UACR) in the range of = 30 but = 3000 mg/g, based on the first assessment for Visit 1
- •3. history of at least one of the following as clinical cause for CKD:
- •? Type 2 diabetes mellitus as defined by the American Diabetes Association (on treatment with glucose-lowering medications and/or insulin) for at least 2 years before randomization and on a stable therapy with sodium-glucose transport protein 2 (SGLT2) inhibitor for at least 3 months before randomization
- •? Diagnosis of hypertension (defined as systolic BP values = 140 mmHg and/or diastolic BP values = 90 mmHg) and on hypertension medication for at least 5 years before randomization
- •4. History of at least one of the following:
- •? established atherosclerotic vascular disease (e.g. coronary artery disease, peripheral arterial disease, cerebrovascular disease)
- •? pulmonary heart disease
- •? heart failure
- •5. Stable treatment with either ACE inhibitors or ARBs at the maximal tolerated labelled daily dose and otherwise stable antihypertensive treatment both for at least 3 months before
- •randomization. If taking an SGLT2 inhibitor, the participant must be on stable treatment for at least 3 months before randomization without any planned changes in dosing during the study period. All treatments must be expected to remain stable over the study period without any planned dose adjustments.
- •6. Body mass index within the range of 18-38 kg/m² as evaluated for Visit 1.
- •7. Male or female. Male participants must agree to use barrier contraception (condoms). Female participants must be of non-child-bearing potential
- •8. Capable of giving signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 48
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 72
排除标准
- •1. Known non-diabetic or non-hypertensive renal disease (e.g. autosomal dominant polycystic kidney disease or autosomal recessive polycystic kidney disease, bilateral clinically relevant renal artery stenosis, lupus nephritis, or ANCA-associated vasculitis, or any other secondary glomerulonephritis)
- •2. Clinical diagnoses of heart failure and persistent symptoms (NYHA class III – IV), or hospitalization for worsening heart failure in the last 3 months prior to signing the ICF
- •3. Uncontrolled hypertension indicated by >160 mmHg systolic BP or =100 mmHg diastolic BP at Visit 1 or Visit 2 or at any unscheduled visit before randomization
- •4. History of secondary hypertension (i.e., renal artery stenosis, primary aldosteronism, or pheochromocytoma)
- •5. Stroke, transient ischemic cerebral attack, acute coronary syndrome in the last 3 months prior to signing the ICF
- •6. Dialysis for acute renal failure within the previous 6 months prior to signing the ICF
- •7. Renal allograft in place or a scheduled kidney transplant within the next 18 weeks from signing the ICF (being on a waiting list does not exclude the participant)
- •8. Hepatic insufficiency classified as Child-Pugh B or C or other significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis as indicated by e.g. AST/ALT >3x ULN)
- •9. Active malignancy. Previous malignancies are allowed if there is a 5-year remission- and treatment-free time before signing the ICF
- •10. Any surgical or medical condition, which in the opinion of the investigator, may place the participant at higher risk from his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study including but not limited to:
- •History of active inflammatory bowel disease within the last 6 months before signing ICF
- •? Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
- •? Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last 6 months before signing ICF (treated duodenal ulcers without bleeding are allowed)
- •? Pancreatic injury or pancreatitis within the last 6 months before signing ICF
- •? A positive test result for SARS-CoV-2 or a diagnosis of COVID-19 within 2 months before signing the ICF
- •11. Evidence of urinary obstruction, e.g. requirement for catheterization or inability to provide urine samples
- •12. Acute or chronic urinary tract infection with bacteriuria, leukocyturia, or hematuria (microscopic investigation to be done upon positive dipstick testing, and participants with hematuria with >5/HPF erythrocytes are excluded from participating in this study)
- •13. Known hypersensitivity to any ingredient of the study intervention
- •14. For participants without diabetes: receiving off-label treatment with an SGLT2 inhibitor
- •15. Indication for immunosuppressants, receiving cytotoxic therapy, immunosuppressive therapy, or other immunotherapy within 6 months prior to signing ICF
- •16. Combination use of an ACE inhibitor and ARB within 3 months prior to signing ICF
- •17. Concomitant therapy with drugs that strongly induce or inhibit CYP3A4, or that are inhibitors of P-gp
- •18. Planned change of concomitant medications or dose adjustments during participation in this study
- •19. Participation in another clinical study with treatment with another investigational product 90 days prior to signing ICF
- •20. Previous randomization in this study or re-screened more t
研究者
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